bsi. By Royal Charter EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. CE 512756 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland In respect of: Design and Manufacture of Ultrasonic Surgical Aspirators and associated sterile and non- sterile accessories, including flues and tips; Tissue Oxygen Partial Pressure (PtO2) and ‘Temperature Monitors; and Intracranial Pressure, Temperature and Oxygen Partial Pressure (Pt02) Monitors. in the manufacture of Those aspects of Annex II relating to securing and maintaining ster sterile disposable wrench sets. (on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086): pal ocacll Stewart Brain, Head of Compliance & Risk - Medical Devices, First Issued: 2007-04-05 Date: 2017-05-11 Expiry Date: 2022-04-04 making excellence a habit” Page 1 of 1bsi. By Royal Charter EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No: cE 512756 Date: 2017-05-11 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland ‘Subcontractor: Service(s) supplied Edwards Lifesciences ETO Sterilization Technology Sért State Road 402, km 1.4 Industrial Park ‘fiasco 00610-1577 Puerto Rico Tategra Burlington MA, Inc Design 85 Rangeway Road Billerica Massachusetts 01862 USA Tintegra LifeScences Corporation Manufacture 4900 Charlemar Drive Bldg A. Cincinnati Ohio 45227 USA making excellence a habit” Page 1 of 3bsi. By Royal Charter EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No: ce 512756 Date: 2017-05-11 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland ‘Subcontractor: Service(s) supplied Tntegra Neurosciences Implants Control of Sterilization (France) S.A. Manufacture 2905 Route Des Dolines Packaging Sophia Antipolis Cedex 06921 France Integra NeuroSciences Control of Sterilization State Road 402, Km 1.2 ‘Aiasco 00610 Puerto Rico Tintegra Pain Management Control of Sterilization 3498 West 2400 South # 1050 Packaging West Valley City Utah 84119 USA making excellence a habit’ Page 2 of 3wt By Royal Charter EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No: cE 512756 Date: 2017-05-11 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland Subcontractor: Service(s) supplied ‘Sterigenics US, LLC ETO Sterilization 5725 W. Harold Gatty Drive Salt Lake City Utah 84116 USA, Sterigenics ETO Sterilization 8 Rue Parmentier Rantigny 60290 France making excellence a habit” Page 3 of 3bsi. ts By Royal Charter EC Certificate - Full Quality Assurance System Certificate History Certificate No: CE 512756 Date: 2017-05-11, Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland Date Reference | ‘Action Number 5 April 2007 First Issue 20 August 2009 | 7433926 Re-issue due to additional sterilization sub-contractor, "Sterigenics International, Inc.’ 27 May 2010 ‘7523808 Re-issue due to addition of ‘Edwards Lifesciences Technology Sarl, Puerto Rico’ to list of significant subcontractors for ETO Sterilization’ ‘30 March 2012 7816212 Certificate renewal and subcontractor name change from “Integra Radionics Inc:’to “Integra Burlington MA, Inc.’ 10 August 2012 | 7831080 Re-issue to extension to scope to include Intracranial Pressure | and Temperature Monitors. 26 September 2013 | 8015515 Reissue due to extension to scope to include Tissue xygen Partial Pressure (PtO2) and Temperature Monitors; and Intracranial Pressure, Temperature and Oxygen Partial Pressure (PtO2) Monitors. Also removal of significant subcontractor Ster-Tech, Inc. making excellence a habit Page 1 of 3bsi. By Royal Charter EC Certificate - Full Quality Assurance System Certificate History Certificate No: CE'S12756 Date: 2017-05-11 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland Date Reference ‘Action Et ‘Number 13 April 2015 8294071 Removal of subcontractor Integra Neurosciences, Andover. Addition of ‘manufacture’ against Integra NeuroSciences, Puerto Rico. 02 February 2016 | 8412743 Reissue due to extension to scope to include, ', including flues and tps’ ‘Addition of subcontractor, ‘Integra NeuroSciences Implants (France) S.A.’ for Packaging Addition of subcontractor, ‘Sterigenics, France’ for ETO Sterilisation. 16 March 2016 | 8483345 ‘Addition of subcontractor, Integra LifeSciences Corporation, 4900 Charlemar Drive Bldg A, Cincinnati, Ohio 45227, USA’ for | manufacture, Removal of subcontractor, ‘sterigenics International, Inc, New | York 12804’ for ETO Sterilization. Change of subcontractor address from, “Integra Burlington MA, Inc,, Massachusetts 01803" to Integra Burlington MA, | Inc, 85 Rangeway Road, Billerica, Massachussets 01862, USA, et and removal of "manufacture" against this subcontractor. making excellence a habit? Page 2 of 3bsi. tee By Royal Charter EC Certificate - Full Quality Assurance System Certificate History Certificate No: cE 512756 Date: 2017-05-11 Issued To: Integra LifeSciences (Ireland) Ltd IDA Business & Technology Park Sragh Tullamore, County Offaly Ireland Date Reference HE ‘Action Bee | Number 21 March 2017 8673694 Renewal of CE 512756. Extension of scope to include products covered by CE 517843; “Those aspects of Annex II relating to securing and ‘maintaining sterility in the manufacture of sterile disposable wrench sets." Changes to activities listed for Integra Neurosciences Implants, addition of ‘Control of Sterilization and Manufacture’. 11 May 2017 8575383 ‘Addition of subcontractors * Integra Pain Management’ for packaging and control of sterilization and 'Sterigenics US, LLC’ In Salt Lake City, Utah, USA for ETO Sterilization. making excellence a habit? Page 3 of 3